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The Acumed Ankle Plating System contains orthopedic plates and lag screws intended for fixation of fractures, osteotomies, and non-unions of the distal tibia and fibula, particularly in osteopenic bone.

The Acumed Small Fragment Base Set contains orthopedic plates and screws with the following indications: Acumed Hook Plates and Locking Peg Hook Plates are intended for fixation of fractures, osteotomies, and non-unions of small bones including the ulna, radius, tibia, and fibula. Acumed Fragment Plates and 4.0mm Cancellous Screws are intended for fixation of fractures, osteotomies, non-unions, replantations, and fusions of small bones and small bone fragments. Acumed One-Third Tubular Plates are intended for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula.

The Acumed Ankle and Small Fragment Base Set Update introduces new 2.7mm and 3.5mm variable angle screws for use with previously cleared plates from the Acumed Ankle Plating System (K143385) and Acumed Small Fragment Base Set (K143394). Additionally, this submission expands the Ankle Plating System to include use of existing 2.7mm and 3.5mm non-locking screws in independent bone fixation, for the K143385 indications.

This is a 510(k) premarket notification for a medical device, not an AI/ML medical device. As such, the document does not contain information about acceptance criteria, study details, or other specifics related to AI/ML device performance or validation. The information provided is for metal bone fixation appliances and accessories.

Therefore, I cannot provide the requested information.

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The Acumed Ankle Plating System is intended for fixation of fractures, and non-unions of the distal tibia and fibula, particularly in osteopenic bone.

The Acumed Ankle Plating System consists of plates and accompanying screws implanted in the distal fibula and tibia. The plates are available in a variety of sizes and use a variety of screw sizes to accommodate varying patient anatomies and fracture patterns. All plates are anatomically pre-contoured, and are provided in left and right limb-specific options where applicable. All implants are manufactured from Ti-6Al-4V per ASTM F136 and provided both sterile and non-sterile. The system contains precontoured plates, 2.7, 3.5, and 4.0mm screws, syndesmosis targeting instrumentation, and other typical instrumentation for ankle plating cases.

This document describes a 510(k) premarket notification for the Acumed Ankle Plating System, a metallic bone fixation appliance. The information provided outlines the device, its intended use, and a non-clinical study conducted to demonstrate substantial equivalence to predicate devices. However, it does not contain the specific details required to answer your request about acceptance criteria and study proving device meets acceptance criteria, as those terms are typically used for AI/ML device performance evaluations.

Here's a breakdown of why the requested information cannot be fully provided from the given text:

• This is a medical device approval, not an AI/ML device approval. The document pertains to an ankle plating system, which is a physical implant, not a software-based or AI device. Therefore, the concepts of "test set," "ground truth," "expert consensus," "MRMC study," "human improvement with AI assistance," or "standalone algorithm performance" are not applicable in this context.
• The "study" described is non-clinical comparative testing. It's a mechanical test to show physical equivalence, not a clinical trial or performance study against specific diagnostic or treatment criteria.

Therefore, many parts of your request are not relevant to this document.

However, I can extract the closest analogous information based on the provided text, focusing on the non-clinical testing performed to establish substantial equivalence.

1. A table of acceptance criteria and the reported device performance

For a physical medical device like an ankle plating system, "acceptance criteria" in this context usually refer to meeting established mechanical performance standards. The document mentions compliance with ASTM F382-99.

2. Sample size used for the test set and the data provenance

• Sample size: Not explicitly stated in the document. ASTM F382-99 outlines standards for material mechanical testing, which typically involves a small number of samples per test condition.
• Data provenance: Non-clinical (laboratory testing)
  • Country of origin: Not specified, but generally performed in a certified testing lab.
  • Retrospective or prospective: N/A for mechanical testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• N/A. This is non-clinical mechanical testing, not a study requiring expert interpretation or ground truth establishment in a clinical sense. The "ground truth" is adherence to mechanical standards.

4. Adjudication method for the test set

• N/A. Adjudication methods like 2+1 or 3+1 are used for clinical judgment of images or outcomes, which is not applicable here. Mechanical tests yield objective measurements.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No. This is not an AI/ML device, and no MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• No. This is not an AI/ML device.

7. The type of ground truth used

• Mechanical performance standards: The "ground truth" for this device's non-clinical testing is its ability to meet specified mechanical properties (e.g., strength, fatigue resistance) as defined by established ASTM standards (ASTM F382-99) and to be substantially equivalent to the predicate device's performance under those standards.

8. The sample size for the training set

• N/A. This is not an AI/ML device, and there is no "training set."

9. How the ground truth for the training set was established

• N/A. There is no training set for this type of device.

In summary, the provided text describes the regulatory clearance of a physical medical device (ankle plating system) based on a non-clinical comparative mechanical study. The questions posed in your request are primarily tailored for AI/ML-based diagnostic or assistive devices, which are not relevant to this specific document.

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The Acumed Small Bone IM Nail System is intended for fixation of fractures of the fibula, and ulna, including fractures where the medullary canal is narrow or flexibility of the implant is paramount.

The Acumed Small Bone IM Nail is a titanium alloy (Ti-6Al-4V) intramedullary rod/nail manufactured in multiple lengths (110mm to 270mm) and diameters (2.6mm to 4.0mm). The nails have openings used in conjunction with titanium alloy cortical screws, which lock them in place. The nails are compatible with an optional far-end locking (FEL) bushing and set screw that provide a locking option at the distal end of the nail. The nails are also compatible with optional end caps that thread into the proximal portion of the nail to provide additional length if desired. All implants are provided both sterile and non-sterile.

The provided text describes a 510(k) premarket notification for the "Acumed Small Bone IM Nail System," which is an intramedullary fixation rod. The document details the device, its intended use, and its substantial equivalence to predicate devices. However, the document does not contain information about acceptance criteria, specific device performance metrics, detailed study designs (sample sizes, ground truth establishment, expert qualifications, adjudication methods), multi-reader multi-case studies, or standalone algorithm performance.

The non-clinical testing section only states that:

"Comparative testing between the Acumed Small Bone IM Nailing system and a predicate device was conducted as per ASTM F1264-03. The test data showed the Acumed Small Bone IM Nail was substantially equivalent to the predicate device in a static four-point bend test, static torsion test, and bending fatigue test as described herein."

This statement confirms that testing was done to demonstrate substantial equivalence, but it does not provide the quantitative acceptance criteria or the specific performance results in a way that allows for the creation of the requested table. It also lacks all other requested information about sample sizes, ground truth, experts, and study types.

Therefore, I cannot fulfill the request to provide the table of acceptance criteria and reported device performance or other detailed study information based on the provided text. The document focuses on regulatory approval through substantial equivalence, which often relies on demonstrating similar physical and mechanical properties to existing devices rather than extensive clinical performance studies with acceptance criteria in the manner requested for AI or diagnostic devices.

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The Acumed Hand Plating System is intended for the management of fractures, fusions, and osteotomies of the distal, middle, and proximal phalanges and metacarpals and other bones of appropriate size for the devices.

The Hand Plating System consists of plates, locking screws, lag screws, and k-wires. Plates are available in a variety of shapes to accommodate varying fracture patterns and/or patient anatomy. The plates come in thicknesses of 0.8 mm to 1.3 mm. The locking screws have major thread diameters of 1.5 mm to 2.3 mm and are provided in lengths ranging from 5 mm to 20 mm. The lag screws have major thread diameters of 1.5 mm to 2.3 mm, provided in lengths ranging from 8 mm to 18 mm.The lag screws and k-wires are used for fixation. The plates are made of titanium per ASTM F-67. The screws, lag screws, and the kwires are made of titanium alloy per ASTM F136.

The provide document is a 510(k) summary for the Acumed Hand Plating System, which is a medical device, not an AI/ML powered device. Typically, 510(k) summaries for such devices focus on demonstrating substantial equivalence to a predicate device through material, design, and intended use comparisons, often supported by mechanical testing rather than clinical study data involving human readers or ground truth for AI algorithms.

Therefore, the requested information, such as acceptance criteria in the context of AI performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth types for AI models, cannot be extracted from this document.

The document states:

• Non-clinical testing: "Engineering analysis was conducted that proved that the 1.5 and 2.3 mm Hexalobe Lag Screws can be used with the Acumed Hand Plates." This indicates mechanical or design verification, not a clinical study as described in your request.
• Substantial Equivalence Comparison: "safety and effectiveness is adequately supported by the substantial equivalence information, materials information, and analysis provided within this Premarket notification. The proposed Acumed Hand Plating System and the predicate devices consist of same technological characteristics, design features, materials of composition, and intended use." This is the primary "proof" for a traditional 510(k) device, not performance against acceptance criteria derived from a clinical study for an AI.

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The Acumed Suture Anchor System is designed to be used for soft tissue fixation in the foot, ankle, knee, hand, wrist, elbow, and shoulder.

The Acumed Suture Anchor System is intended to be used for suture (soft tissue) fixation to bone in the foot, ankle, knee, hand, wrist, elbow, and shoulder.

Shoulder: Rotator Cuff Repair, Bankhart Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular shift or Capsulolabral Reconstruction.

Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Foot/Ankle: Lateral Stabilization, Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair and Bunionectomy.

Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair and Illiotibial Band Tenodesis.

Hand/Wrist: Scapholunate Ligament Reconstruction and Ulnar or Radial Collateral Ligament Reconstruction.

Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair.

The Acumed Suture Anchor System is a system for anchoring soft tissue grafts), using #2 high-strength suture, back to the bone for reattachment. It is available in diameters of 4.5 mm & 5.5 mm in order to accommodate differing anatomic requirements.

The anchor is a screw designed to provide fixation to bone that comes with two, #2 high-strength suture (pre-attached) in order to secure soft tissue (or soft tissue grafts) to the anchor. The system includes Class 1 instruments.

The provided document describes a medical device, the Acumed Suture Anchor System, and its acceptance criteria for 510(k) clearance. However, the study supporting this clearance is a preclinical testing rather than a study involving human subjects or AI algorithms. As such, many of the requested categories related to AI performance, human expert involvement, and ground truth establishment are not applicable.

Here's the information derived from the provided text:

Acceptance Criteria and Reported Device Performance

Study Details

1. Sample Size used for the test set and the data provenance:

   • Not applicable. The study involved preclinical testing of the modified suture anchor, not a test set of data or human subjects.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. The ground truth was based on the physical properties and performance of the device in preclinical testing. No human experts were used to establish a ground truth for a test set.

3. Adjudication method for the test set:

   • Not applicable. This was preclinical testing, not a study requiring adjudication of a test set.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • Not applicable. This was preclinical testing of a medical device, not an MRMC study involving human readers or AI.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This was preclinical testing of a physical medical device, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Preclinical Testing Results: The ground truth was established through physical testing (static and dynamic tension tests) comparing the modified device's performance to the predicate device.

7. The sample size for the training set:

   • Not applicable. There was no training set, as this was preclinical testing of a physical device.

8. How the ground truth for the training set was established:

   • Not applicable. There was no training set. The "ground truth" for the preclinical performance was established via engineering and biomechanical testing standards.

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The Acumed Suture Anchor System is intended to be used for suture (soft tissue) fixation to bone in the foot, ankle, knee, hand, wrist, elbow, and shoulder.

Shoulder: Rotator Cuff Repair, Bankhart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular shift or Capsulolabral Reconstruction.

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair and Bunionectomy.

Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair and Illiotibial Band Tenodesis.

Hand/Wrist: Scapholunate Ligament Reconstruction and Ulnar or Radial Collateral Ligament Reconstruction.

Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis repair.

The Acumed Suture Anchor System is a system for anchoring soft tissue (or soft tissue grafts), using #2 high-strength suture, back to the bone for reattachment. It is available in diameters of 3.5mm & 4.5mm in order to accommodate differing anatomic requirements.

The anchor is a screw designed to provide fixation to bone that comes with two, #2 high-strength suture (pre-attached) in order to secure soft tissue (or soft tissue grafts) to the anchor.

The system includes Class 1 instruments.

The provided document describes the Acumed Suture Anchor System, a medical device for soft tissue fixation to bone. The information primarily focuses on the device's description, intended use, indications for use, technological characteristics, and a comparison to a predicate device for substantial equivalence.

However, the provided text does not contain information related to acceptance criteria or a study proving the device meets specific performance metrics in the way a diagnostic AI/ML device would. This document describes a traditional medical implant, where "performance data" refers to mechanical testing for strength and equivalence to an existing device, not diagnostic accuracy, sensitivity, or specificity.

Therefore, for your specific request that includes acceptance criteria, sample sizes for test sets, ground truth establishment, expert involvement, MRMC studies, or standalone algorithm performance, the provided document does not contain this information.

The "Performance Data" section states:

"The Acumed Suture Anchor System and the predicate were subjected to static and dynamic tension along the axis of the screw as well as static and dynamic tension normal to the axis of the screw. The results demonstrate that the subject components are substantially equivalent to the predicate."

This indicates engineering/mechanical testing to show the new device performs similarly to a previously approved device (the predicate). It does not involve a clinical study with human patients, diagnostic performance metrics, or the establishment of ground truth in a diagnostic sense.

To directly answer your numbered points based on the provided text:

1. A table of acceptance criteria and the reported device performance:

   • Acceptance Criteria: Not explicitly stated as pass/fail thresholds for specific engineering metrics. Instead, the criterion for approval is "substantial equivalence" to the predicate device based on mechanical performance.
   • Reported Device Performance: "The results demonstrate that the subject components are substantially equivalent to the predicate."

   Performance Metric	Acceptance Criteria (Implicit)	Reported Device Performance
   Mechanical Strength (Static and Dynamic Tension along/normal to screw axis)	Performance comparable to predicate device (Arthrex 3.7 mm Bio-Corkscrew (K061863))	Demonstrated substantial equivalence to the predicate.

2. Sample sized used for the test set and the data provenance: Not applicable. This was mechanical testing, not a clinical trial with a "test set" of patients or data provenance in the context of diagnostic AI.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for diagnostic AI (e.g., expert consensus on images, pathology reports) is not relevant for this mechanical testing.

4. Adjudication method: Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No, as it's not an algorithm/AI device.

7. The type of ground truth used: For mechanical testing, the "ground truth" would be the measured physical properties (e.g., tensile strength, fatigue resistance) of the devices under controlled conditions, compared against the known properties of the predicate device. This isn't "expert consensus" or "pathology" in the diagnostic sense.

8. The sample size for the training set: Not applicable, as this is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) summary for a traditional medical device (a suture anchor), and the "performance data" described relates to mechanical testing for substantial equivalence, not the diagnostic performance criteria typically associated with AI/ML devices that would require the detailed information requested in your prompt.

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